Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Phase 3
Terminated
NCT02859896
| Condition | Secondary Hyperparathyroidism-Chronic Kidney Disease |
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| Phase | Phase 3 |
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| Sponsor | Sanofi |
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| Status | Terminated |
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| Enrollment | 21 participants |
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| Interventions | Doxercalciferol (GZ427397), Calcitriol |
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| Start date | Jan 19, 2017 |
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| Completion date | Jun 11, 2025 |
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| Results posted | Jul 2, 2026 |
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Summary
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12
Baseline (Day 1) up to Week 12 · percentage of participants
| Doxercalciferol (Hectorol®) | 14.3 percentage of participants |
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| Calcitriol (Rocaltrol®) | 71.4 percentage of participants |
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| Perecntage difference | -52.9 (95% CI -99.90–-5.98) |
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